Label: CVS EFFERVESCENT PAIN RELIEF PM- acetaminophen and diphenhydramine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-577-16 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 2, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage can occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other product containing diphenhydramine, even one used on skin
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- in children under 12 years of age
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- if you ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- a breathing problem such as emphysema, or chronic bronchitis
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- trouble urinating due to enlarged prostate gland
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- glaucoma
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When Using this product
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- drowsiness will occur
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- avoid alcoholic beverages
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- do not drive or operate machinery
Stop use and ask a doctor if
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- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- redness or swelling is present
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- new symptoms occur
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
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- do not take more than directed (see Overdose warning)
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- dissolve tablets fully in 8 oz of water at room temperature
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- do not chew or swallow tablet
Adults and children 12 years and over
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- take 2 tablets fully dissolved in 8 oz of water at room temperature at bedtime
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- do not take more than 2 tablets in 24 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments
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SPL UNCLASSIFIED SECTION
Distributed By: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket RI 02895
CVS.com
1-800-SHOP CVS
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.
Tamper Evident: Do not use if individual pouch is torn or open. This is not a child resistant package. Keep out of reach of children.
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PRINCIPAL DISPLAY PANEL
Effervescent Pain Relief PM
Extra Strength
Acetaminophen 500mg, Diphenhydramine HCl 25mg
Compare to the active ingredient in Extra Strength Tylenol® PM**
Non-habit forming pain reliever/sleep aid
Aspirin & Ibuprofen free
For a restful night's sleep
No need to chew or swallow tablet
Berry flavor
16 Effervescent Tablets -
INGREDIENTS AND APPEARANCE
CVS EFFERVESCENT PAIN RELIEF PM
acetaminophen and diphenhydramine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-577 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONES (UNII: FZ989GH94E) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color WHITE Score no score Shape ROUND Size 15mm Flavor BERRY Imprint Code RP177 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-577-16 16 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/02/2015 Labeler - CVS Pharmacy (062312574)
